This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA) in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune response in advanced stage Chronic Obstructive Pulmonary Disease (COPD).

Subjects between 45 and 80 years of age with a confirmed diagnosis of advanced stage COPD, not responsive to conventional inhaler therapy, who meet all the study requirements, will be enrolled in this study. A total of 30 subjects of either sex will be enrolled in this study.

The study population (n=30) will be divided into two patient cohorts intended to receive cyclosporine at an initial dosing of 3.0 mg/kg/day or placebo, in a randomized ratio of 1:1.

Other Name: Neoral

Eligibility

Ages Eligible for Study:

45 Years to 80 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age between 45 and 80 years

A confirmed diagnosis of advanced stage COPD, using current accepted diagnostic criteria, including clinical/laboratory findings, pulmonary function tests, and appropriate history to exclude other disorders that could explain their lung disease. The accepted range of FEV1 will include 25% ≤FEV1 ≤ 60%

Subjects agree to maintain a stable medication regimen in the absence of a disease flare

ECOG performance status of 0, 1, or 2

pCO2 < 45 mm Hg, room air oxyhemoglobin saturation > 85%

A willingness to participate in all portions of the protocol, including serial bronchoscopy, requisite surveillances, and ancillary immunologic studies in follow-up visits at this institution

For woman of childbearing age, a negative pregnancy test, and a willingness to use two methods of contraception, or abstinence

An ability and willingness to provide written informed consent

Exclusion Criteria:

Three, or more exacerbations of lower respiratory disease in the past year requiring systemic corticosteroids, or one exacerbation requiring hospitalization in the past 6 months

Intubation for COPD, or other cause of respiratory failure in the past year

Use of immunosuppressive therapy including oral prednisone > 10mg per day other than aerosolized corticosteroids, anytime within three months prior to participation

Evidence for an opportunistic infection/colonization of the airways, i.e., non-bacterial

Concurrent participation in other clinical trials within the prior month

Known medical or psychological condition (severe personality disorder or mental illness) that would not permit the subject to complete the trial or sign informed consent

Autoimmune disorders or other disorders with suspected systemic immune involvement

Active smoking history or urinary cotinine > 2

Hypersensitivity to midazolam or narcotics which would not allow bronchoscopy sedation

Concurrent use of drugs with a known interaction with cyclosporine

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974142